Clifford Chance
U.S. Healthcare AI Developments: California's New Healthcare-focused genAI Law
As the healthcare industry develops novel uses for artificial intelligence (AI) and generative AI (genAI), various U.S. state regulators have responded. In particular, California, Colorado, Illinois, New York, and Utah have each introduced laws regulating AI in healthcare, ranging in scope.
Of particular note is a new law in California, AB 3030, regulating genAI use in patient communications and set to take effect on January 1, 2025.
This new CA law requires health facilities, clinics, physician's offices, and offices at a group practice to provide certain disclosures when using genAI to generate written or verbal patient communications pertaining to patient clinical information. "Patient clinical information" is "information relating to the health status of a patient" and does not include administrative matters.
Specifically, providers are required to include a disclaimer that indicates to the patient that the communication was generated by genAI. The disclaimer requirements vary depending on the form of communication as follows:
- For written communications involving physical and digital media (e.g., letters and email), the disclaimer must appear prominently at the beginning of the communication.
- For continuous written online communications (e.g., chat messaging), the disclaimer must be prominently displayed throughout the interaction.
- For audio communications, the disclaimer must be provided verbally at the beginning and end of the communication.
- For video interactions, the disclaimer must be prominently displayed throughout the video interaction.
The law also requires that the communication include clear instructions for how a patient may contact a human member of their healthcare team.
The above requirements do not apply where a licensed or certified healthcare provider has reviewed the communication before sending it to the patient.
Physicians that violate the new law are subject to the jurisdiction of the Medical Board of California or the Osteopathic Medical Board of California, while licensed health clinics in violation are subject to enforcement under the California Health and Safety Code.
As genAI continues to become a prominent part of our day-to-day life, including healthcare, healthcare providers and facilities must pay close attention to evolving regulations and ensure that their AI applications remain compliant. Clifford Chance, with an integrated global legal team that spans the US, UK, continental Europe, the Middle East, and Asia, is uniquely situated and happy to advise on this developing regulatory landscape.